Recently, the Hainan Free Trade Port temporarily adjusted the application of relevant provisions of the Food Safety Law of the People's Republic of China. Specific domestic patients, including patients with rare diseases, can simultaneously obtain health food and food for special medical purpose legally listed overseas in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the Lecheng Pilot Zone).

Industry insiders believe that the new policy will promote the development of the "medical special zone" and the health and medical industry that is matched with licensed drugs and medical devices, food for special medical purpose, etc., and expand the service chain of health industry. At the same time, the new requirements for the safety supervision of health food and food for special medical purpose also be put forward.

Meeting urgent clinical needs

From the perspective of actual needs, there is a huge demand for health care and food for special medical purpose in China, but the supply of listed products is seriously insufficient, far from meeting clinical requirements. Enterprises, medical institutions, and especially patients with rare diseases have strong expectations for imported health food and food for special medical purpose from the Lecheng Pilot Zone, which has a special drug and device import policy.

From the perspective of supporting policies, the State Council delegated the approval authority of licensed drugs and medical devices to Hainan in 2018. Since 2018, the Lecheng Pilot Zone has introduced more than 400 international licensed drugs and medical devices, becoming the main channel for international innovative drugs and medical devices to enter China. This adjustment of the law authorization can meet the clinical needs of specific populations for innovative products in customized nutritional support.

Good news for industrial development

The temporary adjustment of the application of relevant provisions of the Food Safety Law of the People's Republic of China in the Hainan Free Trade Port means that specific domestic patients, especially those with rare diseases, will have a safe and reliable way to obtain health food and food for special medical purpose that have been legally listed in foreign countries in the Lecheng Pilot Zone. Foreign enterprises will also have a channel to Chinese consumers directly.

Prevent and control risks to ensure safety

In the implementation of the licensed drug and device policy, Hainan has accumulated experience in system norms, implementation measures, risk prevention, etc., and the supervision capacity has been significantly improved, which can provide reference for the management of imported health food and food for special medical purpose. Hainan will implement strict review, approval and supervision on health food and food for special medical purpose imported for use in the Lecheng Pilot Zone, and strictly limit products' use area, use organization, user population, usage, etc., which should be provided to specific patients and health care groups under the guidance of doctors and professional nutritionists in medical institutions in the Lecheng Pilot Zone, without exceeding the reasonable required amount.

In addition, to ensure food safety, Hainan Province is building a traceability management platform for imported special food in the Lecheng Pilot Zone. Imported health food and food for special medical purpose will be included in the platform from the beginning of customs clearance to implement seamless management throughout the process, so as to timely discover and control safety risks.

Source: Economic Information Daily

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